Foods, Dietary Supplements, Nutritional Support

Question 1

What makes a product a drug?

Answer 1

• Supplier makes a health or therapeutic claim or a structure/function claim
• Article intended to diagnose, cure, mitigate, treat, or prevent a disease
• Manufacturer/supplier’s intended use is key not the purchaser’s intent

Question 2

What is special dietary food?

Answer 2

Those supplying a special dietary need that exists by reason of a physical, psychological, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allegoric hypersensitivity to food, underweight, overweight or the need to control the intake of sodium
Ex: artificial sweeteners, and caloric supplements

Question 3

What is medical food?

Answer 3

Foods formulated for oral use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation
Ex: foods formulated without the amino acid phenylalanine for phenylketonuria and folic acid, B6, or B12 combination products for hyperhomocysteinemia

Question 4

What are nutraceuticals and functional foods?

Answer 4

An additional classification of food that includes foods that provide health or medical benefits including the prevention and treatment of disease
Functional foods have been enhanced or fortified, often with a dietary supplement, like drinks with kava kava added or foods fortified with calcium, or yogurt with probiotics

Question 5

Health claims for foods?

Answer 5

Food manufacturers make health claims for foods (current tv ads for common foods). Ex: Cheerios 2009

Question 6

(T/F) The FDA regulates dietary supplements more as a special type of food than a drug

Answer 6

True

Question 7

(T/F) Dietary supplements require premarket approval

Answer 7

False

Question 8

Who is responsible for determining if a dietary supplement product is safe and that the claims about the product are substantiated by adequate evidence?

Answer 8

Manufacturer

Question 9

Do manufacturers have to provide substantiating evidence about safety to the FDA?

Answer 9

No

Question 10

(T/F) The FDA has to prove an item is unsafe before it can remove an article from the market

Answer 10

True

Question 11

What is the role of pharmacists regarding dietary supplements?

Answer 11

To provide accurate information to patients and assisting them in selecting products. Must present an informed and balanced view using expertise and research

Question 12

What are the four types of statement the FDA will allow dietary supplement suppliers to make if the seller has substantiation that they are truthful, and not misleading, and the label of the product contains the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Answer 12

1. That the product will benefit a classical nutritional deficiency disease as long as it also discloses the prevalence of the disease in the US
2. The describe the role of the dietary supplement in affecting the structure of function of the body
3. That characterize the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function
4. That describe the general well-being from consumption of a nutrient or dietary ingredient (energizer, relaxant, muscle enhancement)

Question 13

Are manufacturers allowed to make unapproved health (disease) claims that fall under part B of the drug definition?

Answer 13

No, the Dietary Supplement Health and Education Act does not allow these claims

Question 14

When shall the FDA authorize a health claim to be used on conventional foods?

Answer 14

If the agency determines based on the totality of the publicly available evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence

Question 15

What is a product contains dietary supplement and compound that was approved as a new drug?

Answer 15

Ex: Cholestin
FDA decided it was a drug and Pharmanex v. Shalala challenged the decision that the product containing red yeast rice was a dietary supplement
The Court upheld FDA’s decision since the product contains significant amounts of lovastatin, a drug approved in 1987 for lowering cholesterol. Moreover, Pharmanex included high levels of lovastatin not found in traditional red yeast rice

Question 16

How many days for manufacturers, packers, or distributors whose name appears on the label of nonprescription drugs and dietary supplements have to submit any report of serious adverse events to the Secretary of DHHS (through MedWatch Program)?

Answer 16

Within 15 business days

Also must submit subsequent medical information received within 1 year of initial reported event

Question 17

What is the independent, private organization founded by physicians and pharmacists that was published by the United States Pharmacopeial Convention?

Answer 17

United States Pharmacopoeia

Question 18

What is the private nonprofit organization of experts in homeopathy that was established by the Homeopathic Pharmacopoeia Convention of the US?

Answer 18

HPUS